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An international, five-arm randomised trial of carboplatin and paclitaxel versus triplet or sequential doublet combination in patients with epithelial ovarian cancer or primary peritoneal carcinoma
ISRCTN ISRCTN41636183
DOI 10.1186/ISRCTN41636183
ClinicalTrials.gov identifier NCT00011986
EudraCT number
Public title An international, five-arm randomised trial of carboplatin and paclitaxel versus triplet or sequential doublet combination in patients with epithelial ovarian cancer or primary peritoneal carcinoma
Scientific title
Acronym ICON5/GOG182
Serial number at source E164/58
Study hypothesis To evaluate a variety of chemotherapy regimes for patients with advanced stage (FIGO III-IV) epithelial ovarian or serious primary peritoneal carcinoma. Efficacy will be determined through analysis of overall survival and progression free survival.

The trial will also compare the toxicities and adverse effects of each treatment regimen, describe the dose density and collative dose delivery for each regime, compare response rates in patients with measurable disease. In the UK, evaluate the impact of regimes on quality of life, evaluate the impact of regimes on resource use and quality-adjusted life-years, collect and store genetic material for future studies of molecular genetics.

The trial includes two stages, at the end of the first stage only those treatment arms that appear promising on the basis of progression free survival will continue in to the second stage which aims to evaluate the impact of the regimes on overall survival.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Ovarian cancer and peritoneal carcinoma
Participants - inclusion criteria 1. Stage III or IV ovarian or serious primary peritoneal carcinoma, following appropriate surgery
2. Tumor tissue available for histological evaluation
3. Adequate bone marrow liver kidney and neurological function
4. World Health Organisation (WHO) performance status zero to two
5. Fit and able to take part in trial treatments and follow-up
6. Informed consent
Participants - exclusion criteria 1. Concomitant or previous malignancies likely to interfere with protocol treatments
2. Patient has received radiotherapy or chemotherapy to any abdominal or pelvic tumour
3. Acute hepatitis, infection or Gastrointestinal bleeding
4. Women of childbearing age who will not use adequate contraception or are breastfeeding
Anticipated start date 01/03/2002
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material
Target number of participants 4000
Interventions Arm I: Taxol 175 mg/m^2 day one, Carboplatin AUC6 or AUC(EDTA)5 iv day one, eight cycles
Arm II: Taxol 175 mg/m^2, day one, Gemzar 800 mg/m^2 days one and eight, Carboplatin AUC5 or AUC(EDTA)4, day one, eight cycles
Arm III: Taxol 175 mg/m^2 day one, Caelyx 30 mg/m^2 day one every other cycle, Carboplatin AUC5 or AUC(EDTA)4 day one, eight cycles
Arm IV: Hycamtin 1.25 mg/m^2 days one, two and three, Carboplatin AUC5 or AUC(EDTA)4 day three, four cycles, then four cycles of Arm I
Arm V: Gemzar 1000 mg/m^2, days one and eight, Carboplatin AUC6 or AUC(EDTA)5 day eight, four cycles then four cycles of Arm I

In every case cycles are 21 days long. Chemotherapy continues unless disease progression or unacceptable toxicity occurs. Dose reductions or delays for toxicity are defined in the full protocol.
Primary outcome measure(s) Overall survival.
Secondary outcome measure(s) 1. Progression free survival
2. Response rate (in patients with measurable disease)
3. Toxicity and symptoms
4. Dose and dose intensity
5. Patients assessment of quality of life and acceptability of treatment, health economics
6. Molecular genetics (future study)
Sources of funding Medical Research Council (MRC) (UK)
Trial website http://www.ctu.mrc.ac.uk/studies/ICON5.asp
Publications Results:
1. 2003 results: http://www.ncbi.nlm.nih.gov/pubmed/12927999
2. 2009 results: http://www.ncbi.nlm.nih.gov/pubmed/19224846
Contact name Dr  P  Harper
  Address Medical Oncology
3rd Floor Thomas Guy House
Guy's Hospital
St Thomas Street
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
  Email
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 18/05/2001
Last edited 20/09/2012
Date ISRCTN assigned 18/05/2001
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